510(k) Report

Devices descending from K120027

7 later devices reach Pilairo Nasal Pillows Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+2K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+3K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+3K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+3K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+4K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+4K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—